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Goodwin Procter LLP | USA | 13 May 2022

Henlius and Eurofarma Entered into a License Agreement for Henlius’ 3 Products in Latin America

Shanghai Henlius Biotech, Inc. (“Henlius”) announced this week that it has entered into a license and collaboration agreement with Eurofarma…
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De Berti Jacchia Franchini Forlani Studio Legale | European Union, Italy | 13 May 2022

Le principali novità 2022 del Codice Deontologico di Farmindustria

In data 19 gennaio 2022, Farmindustria ha introdotto diverse novità al proprio Codice Deontologico, l'accordo fra le industrie farmaceutiche…
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MinterEllison | Australia | 13 May 2022

New regulatory framework for sharing Commonwealth public sector data - the DATA Scheme

The DATA Act establishes a new regulatory framework for the controlled sharing of Commonwealth 'public sector data'. The Act authorises (but does not…
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Reed Smith LLP | USA | 13 May 2022

Design Defect Claim Dismissed in W.D.N.Y. Fosamax Case

We write today from a room in a rehabilitation facility, where we just shared the Drug and Device Law Dowager Countess's lunch. The Countess, nearly…
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Harris Bricken | China | 13 May 2022

The Real Meaning of COVID-zero.

I got an email from a friend/client yesterday and I liked it so much I got his approval to run it, lightly edited to strip out any possible…
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CMS, China | China | 13 May 2022

Highlights on Administrative Provisions on Drug Annual Reporting

Issued by the National Medical Products Administration ("NMPA") on 11 April 2022, the Administrative Provisions on Drug Annual Reporting…
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Goodwin Procter LLP | USA | 13 May 2022

FDA Testimony Before the U.S. Senate Regarding Reauthorization of the Biosimilar User Fee Act

This week Patrizia Cavazzoni (Director, CDER), Peter Marks (Director, CBER), and Jeffrey Shuren (Director, CDRH) of the FDA testified before the…
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SP Law | Brazil | 13 May 2022

Telemedicine’s New Horizons in Brazil

While new paths have emerged for telemedicine in Brazil, only doctors and companies duly registered in the country may avail themselves of this…
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JPM Jankovic Popovic Mitic | Serbia | 12 May 2022

CANCELATION of COVID-19 Restrictive Measures for Entering the Republic of Serbia

More countries, that have, until recently, been considered the pandemic’s epicenter, are easing COVID restrictions. Serbia takes the same direction…
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Bristows | European Union, United Kingdom | 12 May 2022

Spotlight on IVDR - Why we keep banging on about Notified Bodies

Long-time readers of On the Pulse will know that Notified Body capacity under the new European medical devices regulatory framework, has long been a…
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